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Effects of Growth Hormone Releasing Hormone in HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01263717
First received: December 16, 2010
Last updated: October 10, 2014
Last verified: October 2014
History of Changes
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Lipodystrophy
Interventions: Drug: tesamorelin
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tesamorelin Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo (Inactive Injection) Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase

Participant Flow:   Overall Study
    Tesamorelin   Placebo (Inactive Injection)
STARTED   28   26 
Baseline Visit   28   22 
COMPLETED   23   20 
NOT COMPLETED   5   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tesamorelin Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo (Inactive Injection) Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Total Total of all reporting groups

Baseline Measures
   Tesamorelin   Placebo (Inactive Injection)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 28   22   50 
Age 
[Units: Years]
Median (Inter-Quartile Range) 		 49 
 (46 to 54)  		 53 
 (49 to 58)  		 51.5 
 (46 to 56.25) 
Gender 
[Units: Participants]
 		     
Female   4   4   8 
Male   24   18   42 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
White   20   14   34 
Black   6   3   9 
Hispanic   1   3   4 
Other   1   2   3 
Region of Enrollment 
[Units: Participants]
 		     
United States   28   22   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Liver Fat   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Primary:   Visceral Adipose Tissue   [ Time Frame: 6 months ]
  Show Outcome Measure 2

3.  Secondary:   Intramyocellular Lipid   [ Time Frame: 6 months ]
  Show Outcome Measure 3

4.  Secondary:   Endogenous Growth Hormone Secretion   [ Time Frame: 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Insulin Sensitivity   [ Time Frame: 6 months ]
  Show Outcome Measure 5

6.  Secondary:   HbA1c   [ Time Frame: 6 months ]
  Show Outcome Measure 6

7.  Secondary:   Insulin Like Growth Factor 1 (IGF-I)   [ Time Frame: 6 months ]
  Show Outcome Measure 7

8.  Secondary:   Lipid Panel   [ Time Frame: 6 months ]
  Show Outcome Measure 8

9.  Secondary:   Carotid Intimal Medial Thickness (cIMT)   [ Time Frame: 6 months ]
  Show Outcome Measure 9

10.  Secondary:   Glucose Tolerance   [ Time Frame: 6 months ]
  Show Outcome Measure 10

11.  Secondary:   Adiponectin   [ Time Frame: 6 months ]
  Show Outcome Measure 11

12.  Secondary:   Hemostatic Markers   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven K. Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org


Publications of Results:


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263717     History of Changes
Other Study ID Numbers: 2007p-000638
Study First Received: December 16, 2010
Results First Received: September 8, 2014
Last Updated: October 10, 2014